The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients

Обзор

Autologous CAR-T cell therapy in HIV-1/AIDS patients

Вмешательства

• Биопрепарат HIV-CAR-T
  Intravenous Infusion of CAR-T Cells

Первичные конечные точки

• Incidence of adverse reactions [Срок оценки: Up to 12 Weeks After CAR T-cell Infusion]

Вторичные конечные точки (1)

• HIV-1 RNA level [Срок оценки: Up to 12 Weeks After CAR T-cell Infusion]

Критерии участия

Критерии включения

• Age between 18 and 65 years;
• Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels <50 copies/mL for the 12 months preceding enrollment;
• CD4+ T-cell count >350/μl within 30 days prior to enrollment;
• Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures;
• Willingness to provide true identity information and comply with follow-up requirements;
• Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.

Критерии исключения

• Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
• Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
• History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
• Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
• Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
• Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
• Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
• Abnormal laboratory results within 14 days prior to enrollment meeting any of the following:

Hemoglobin <10 g/dL (female) or <11 g/dL (male) Absolute neutrophil count <1 ×10⁹/L Platelet count <100 ×10⁹/L Serum creatinine >110 μmol/L INR >1.5 or PTT >45 seconds ALT or AST >2.5 × upper limit of normal (ULN) Total bilirubin >1.5 × ULN

• Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
• Any other condition deemed inappropriate for participation by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sci — Тяньцзинь

Идентификаторы

NCT: NCT06880380 · IIT2024087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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